Recall Z-2596-2010 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Hemostatix Medical Technologies LLC
MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF 7013-8050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC, BARTLETT, TN 38133 USA, CE 0473, EU REP : QFI LTD, STRATFORD, LONDON E15 2ST UK The Hemostatix Thermal Scalpel is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel while minimizin
| Date | Sep 28, 2010 (initiated Jul 27, 2010) |
| Status | Terminated |
| Reason | Lack of sterility assurance |
| Root cause | Other |
| Action | On July 27, 2010, the firm, Hemostatix Medical Technologies, LLC, notified their international distributor in Japan of the recall by email. Hemostatix sent an "URGENT: MEDICAL DEVICE RECALL" letter dated July 29, 2010, to U.S. customers delivered via FedEx Priority Overnight. All non-responding customers were to be notified by telephone after 2 weeks. The other international customer, Italy, were to be notified by email on July 30, 2010. The letter describes the product, problem and action to be taken by customers. The customers were instructed to immediately check their inventory and remo |
| Quantity | 40 units |
| Distribution | Worldwide distribution: USA including CA, GA, LA, MA, MD, MO, NC, OH, OR, PA, SC, TX, VA, and WI; and countries of Japan and Italy. |
| FDA record | Open on fda.gov |